The present invention relates generally to PTFE tubes, preferably ePTFE tubes for use as luminal prostheses. More particularly, the present invention relates to a method of forming a PTFE tube having a reduced wall thickness and larger diameter.
The use of products formed from polytetrafluoroethylene (PTFE) tubes in medical applications is well known. Products such as implantable grafts, covered stents, catheter tubing and the like may be formed from tubes of PTFE. One technique for forming PTFE tubing is to use a wet flow paste extrusion process. The paste extrusion process yields a green tube which is then subjected to secondary operations such as heating, expansion and sintering to yield a porous expanded PTFE (ePTFE) tube having a porous node and fibril structure which optimizes its use in medical applications.
Often, the green tube produced by the paste extrusion process has a relatively thick wall and a small internal diameter. The secondary operations of expanding the tube and subsequently sintering the tube results in a certain degree of thinning of the wall of the tube. However, the expansion process currently being used limits the amount of thinning or circumferential orientation that can be achieved in the wall thickness of the tube. In certain applications, the resultant ePTFE tube may still exhibit a sufficiently large wall thickness making it difficult to use in certain medical applications. Additionally, extrusion process results in the extruded tube being highly oriented in a single (longitudinal) direction. Thus the tube would exhibit reduced strength in the transverse or circumferential direction. The secondary operations do little to improve the circumferential strength of the tube.
In instances where an extruded ePTFE tube is being used to form an implantable luminal prosthesis, the thickness and circumferential strength of the tube are of particular concern.
For example, a relatively thick tube may be more difficult to implant, especially where the prosthesis is designed for endoluminal delivery. Furthermore, in situations which require multiple layer prostheses, such as with a graft formed by a tube-over-tube construction, or where the ePTFE tube is being used to form a stent/graft composite structure having a stent employed in combination with one or more graft layers, the wall thickness of the ePTFE tube is of particular concern. With grafts formed of multiple layered tubes, the porosity of the graft may be affected by the thickness of the structure. In stent/graft composite structures, the thickness of the ePTFE tube may render the delivery and deployment of the composite structure difficult. Moreover, circumferential strength is required both during implantation as well as in use. The prosthesis must be capable of withstanding expansion upon deployment and must also withstand the internal pressure of blood flow in use.
It is, therefore, desirable to provide a method and apparatus for forming a PTFE green tube of reduced wall thickness that imparts a degree of circumferential orientation to a PTFE green tube.
It is an object of the present invention to provide a process for reducing the wall thickness of a PTFE tube and circumferentially orientating the nodal structure
It is a further object of the present invention to provide a process for increasing the circumferential strength of the PTFE tube by circumferentially orienting and thinning the wall, while simultaneously increasing the diameter of the tube.
It is a still further object of the present invention to provide a thin wall PTFE tube formed from an extruded tube where the wall thickness of the extruded tube has been reduced and circumferentially oriented.
In the efficient attainment of these and other objects, the present invention provides a method for forming a circumferentially oriented thin wall PTFE tube. The PTFE tube includes an inner tubular surface and an opposed outer tubular surface defining a tubular wall of a first thickness. The PTFE tube is positioned over a first elongate roller with the inner surface of the tube being in contact therewith. A second surface is positioned against the outer tubular surface of the PTFE tube. The first surface is rotated relative to the second surface to compress the tubular wall between the surfaces thereby uniformly reducing the tubular wall from the first thickness to a lesser second thickness and providing circumferential orientation to the tube.
As more particularly described by way of preferred embodiments, a second roller defining the second surface is brought into contact therewith so as to effect compression of the tubular wall therebetween. Counter-rotation of the first and second rollers may be achieved by rotating the first roller which is maintained in contact with the second roller. The present invention further provides for secondary tensioning rollers which are positioned with the inner surface of the tube. The secondary tensioning rollers maintain a tensioning bias against the inner surface of the tube. These rollers serve to take up the slack created from the diameter enlargement and thinning process to prevent the tubular walls from being pinched between the first and second rollers.
Another aspect of the invention provides for placing the tube over a first elongate luminal roller, the outer rolling surface contacting the inner tubular surface. The assembled configuration is then placed within a larger, substantially hollow cylindrical elongate roller. A tensioning bias is applied to the first roller, thereby squeezing the tubular material between the outer rolling surface of the luminal roller and the interior circumferential surface of the hollow roller. A rotational force is then applied to the first roller, causing rotation of the first roller and PTFE tube mounted thereon providing for thinning of the PTFE tube.
Another embodiment of the invention provides for placing the tube on an elongate roller and utilizing a smooth surface as the second surface. Additionally, it is contemplated to utilize two opposing rolling surfaces positioned substantially parallel on opposing sides of the tube and roller assembly.
Preferably, the process of the present invention is achieved in a warm water bath and the PTFE tube includes a lubricant to facilitate processing.